Quality Systems Manager

3 weeks ago


Lewisville, Texas, United States Orthofix Full time

Why Orthofix?

We're guided by our organizational values: Take Ownership, Innovate Boldly, and Win Together. Our team collaborates closely with world-class surgeons and partners to improve people's quality of life. At Orthofix, we want team members who build relationships, share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision.

As a Senior Quality Engineer, you'll have the opportunity to work on highly innovative medical technologies that make a real difference in people's lives. You'll be part of a global team that brings cutting-edge medical devices to market, improving the lives of patients and healthcare professionals worldwide.

Your Key Responsibilities

  • Develop and maintain inspection plans using appropriate methodologies to ensure products meet specifications and are safe/effective for use.
  • Support sustaining activities, quality control, and calibration department, including developing and maintaining inspection plans, facilitating MRB activities, and conducting out-of-tolerance investigations.
  • Use quality engineering tools for problem-solving, identify opportunities for continuous improvement, and interact and coordinate activities with other departments, external vendors, and customers.
  • Assist or lead in the prompt implementation of quality-related projects, including non-conformance resolution, complaint investigation and corrective/preventative action (CAPA), process validations, and development and implementation of new and updated quality system procedures.
  • Participate in FDA inspections, ISO certification and surveillance audits, and customer audits.

Your Qualifications

  • Bachelor's Degree in Engineering, Science, or a related field.
  • Minimum 5 years' experience in quality engineering or a related field.
  • Understanding of medical device quality system requirements, including 21 CFR 820, ISO 13485, and ISO 14971.
  • Strong technical skills, ability to provide solutions to technical problems of moderate scope and complexity, and demonstrated experience in using statistical tools.
  • Able to independently manage projects and lead cross-functional teams.

Estimated Salary: $125,000 - $165,000 per year


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